Bone graft delivery system and method for using same

ABSTRACT

A bone graft delivery system can include an elongate tube and a handle having a trigger and a ratcheting mechanism. The trigger is actuated to deliver bone graft material through the tube. The bone graft delivery system can further include a distal tip at a distal end of the tube. The tip has one or more openings to deliver the bone graft material to a desired location and includes a surface suitable to act as a rasp for decorticating bone. A method for delivering bone graft material to a desired surgical location includes providing a bone graft delivery device, positioning the device adjacent the surgical location, decorticating bone, and delivering bone graft material to the surgical location.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57. Thisapplication is a continuation of U.S. patent application Ser. No.15/614,435, filed Jun. 5, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/214,031, filed Mar. 14, 2014, and issued as U.S.Pat. No. 9,668,881 on Jun. 6, 2017, which claims priority benefit ofU.S. Provisional Application Nos. 61/798,513, filed Mar. 15, 2013, and61/883,940, filed Sep. 27, 2013, the entirety of each of which is herebyincorporated by reference herein and should be considered a part of thisspecification.

BACKGROUND Field

The present application relates to orthopedic surgery in general, andmore particularly, to bone graft delivery systems and methods.

Description of the Related Art

In a bone grafting procedure, a surgeon places bone or a bone substituteinto an area in a patient's body to provide a type of scaffold for bonegrowth and repair. Bone grafts can be used to help treat variousorthopedic problems, for example, to fuse a joint or repair a fracture.Bone graft material can be, for example, autogenous (harvested from thepatient's own body), allogeneic (harvested from another person, usuallya cadaver), or synthetic. Many bone grafting procedures are performedvia open surgery implantation. However, these procedures can also beperformed minimally invasively, for example, by using a needle to injectthe bone graft material into the target location without requiring asurgical incision.

In some cases decortication of the bony area receiving the graft isperformed prior to delivery of the bone graft material. Decorticationremoves superficial cortical bone and exposes the underlying cancellousbone, which can help accelerate the integration of the bone graft withthe native bone.

SUMMARY

The devices, systems, and methods described herein allow for minimallyinvasive delivery of bone graft material to a desired location in apatient's body. In some embodiments, the devices, systems, and methodsdescribed herein allow for delivery of bone graft material to a desiredlocation in an open or mini-open procedure. In some embodiments, thedevices, systems, and methods described herein also provide for bonedecortication.

In some embodiments, a bone graft delivery system includes an elongatedtube, a handle at a proximal end of the tube, and a tip at a distal endof the tube. The handle is configured to be actuated to deliver bonegraft material through the tube. The tip includes one or more openingsconfigured to deliver the bone graft material to a desired location anda surface suitable to serve as a rasp for scraping bone.

In some embodiments, the rasping surface of the tip includes jaggededges. The tip can be made of a metal, a radiopaque material, a durablemedical plastic, a composite material, or another material orcombination of materials. In some embodiments, the tip includes one ormore radiopaque markers. The tip can have a sharp or blunt end. The tipcan be removably attachable to the distal end of the tube.Alternatively, the tip can be integrally formed or permanently coupledto the distal end of the tube. In some embodiments the tube is rigid. Inother embodiments the tube is at least somewhat bendable. In someembodiments the tube is straight, while in other embodiments the tubeincludes a permanent bend. The handle can include a trigger configuredto be actuated to deliver the bone graft material through the tube. Insome embodiments, the bone graft delivery system includes an endoscopiccamera positioned adjacent the tip.

In some embodiments, a method for delivering bone graft material to asurgical location includes providing a bone graft delivery device andpositioning the device adjacent the surgical location. The bone graftdelivery device comprises an elongate tube and a distal tip. The distaltip includes at least one opening for delivering the bone graft materialto the surgical location. The method further includes decorticating bonewith the distal tip and delivering bone graft material through the tubeand out the at least one opening of the tip.

The bone graft material can be one or more autogenous, allogenic,cadaveric, and/or synthetic materials. In some embodiments, the bonegraft delivery device is positioned at the surgical location through aminimally invasive opening in a patient's skin. In some embodiments, thesurgical location is a portion of the patient's spine, so the bone graftdelivery device is positioned adjacent to the spine and the distal tipdecorticates a portion of the spine. In some embodiments, decorticatingbone with the distal tip is accomplished by rasping bone with jaggededges of the distal tip. In some embodiments, bone is decorticated withthe distal tip by actuating the distal tip with mechanical, batterypowered, electric, pneumatic, or other means of force.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a side view of an example embodiment of a bone graftdelivery device;

FIG. 1B illustrates a perspective view of the bone graft delivery deviceof FIG. 1A;

FIGS. 2A and 2B illustrate perspective views of another exampleembodiment of a bone graft delivery device;

FIG. 2C illustrates a side view of another example embodiment of a bonegraft delivery device;

FIG. 2D illustrates a section view of the bone graft delivery device ofFIG. 2C;

FIG. 2E illustrates a section view of the bone graft delivery device ofFIGS. 2C and 2D including a pusher rod;

FIG. 2F illustrates a side view of another example embodiment of a bonegraft delivery device;

FIG. 2G illustrates a section view of the bone graft delivery device ofFIG. 2F;

FIG. 2H illustrates a section view of the bone graft delivery device ofFIGS. 2F and 2G including a pusher rod;

FIG. 2I illustrates a bottom view of another example embodiment of abone graft delivery device;

FIG. 2J illustrates a section view of the bone graft delivery device ofFIG. 2I;

FIG. 2K illustrates a section view of the bone graft delivery device ofFIGS. 2I and 2J including a pusher rod;

FIG. 3 illustrates a perspective view of a handle of a bone graftdelivery device including a funnel for introduction of bone graft;

FIGS. 4A-4E are section views illustrating operation of an exampleembodiment of a ratcheting mechanism in a handle of a bone graftdelivery device;

FIGS. 4F and 4G illustrate exploded views of an example embodiment of abone graft delivery device including a ratcheting mechanism;

FIGS. 4H-4M illustrate operation of the ratcheting mechanism of thedevice of FIGS. 4F and 4G;

FIG. 4N illustrates a perspective view of an example embodiment of abone graft delivery device including a ratcheting mechanism;

FIG. 4O illustrates an exploded view of the bone graft delivery deviceof FIG. 4N;

FIGS. 4P-4T are section views illustrating operation of the ratchetingmechanism of the device of FIGS. 4N and 4O;

FIGS. 4U and 4V illustrate section views of an example embodiment of ahandle of a bone graft delivery device including a ratcheting mechanism;

FIG. 4W illustrates a radiopaque ring configured to be placed on adistal end of a tube of a bone graft delivery device;

FIG. 4X illustrates a section view of a distal end of a plunger of abone graft delivery device;

FIGS. 5A and 5B illustrate an example embodiment of a bone graftdelivery device having a modular handle and tube construction;

FIGS. 6A-6C illustrate various views of a distal tip of the bone graftdelivery device of FIGS. 1A and 1B;

FIG. 6D illustrates a perspective view of an example embodiment of abone graft delivery device having a curved tube;

FIG. 6E illustrates a perspective view of an example embodiment of abone graft delivery device having a straight tube;

FIG. 6F illustrates an enlarged view of a rasping distal tip of the bonegraft delivery device of FIG. 6E;

FIG. 6G illustrates the distal tip of FIG. 6F extruding bone graftmaterial;

FIG. 6H illustrates an example embodiment of a rasping distal tipcoupled to a tube of a bone graft delivery device;

FIG. 6I illustrates the distal tip of FIG. 6H extruding bone graftmaterial;

FIG. 7A illustrates a perspective view of an example embodiment of abone graft delivery device;

FIG. 7B illustrates a perspective view of an example embodiment of abone graft delivery device including a shaft having a distal burrdisposed therethrough;

FIG. 7C illustrates an enlarged view of the distal end of the bone graftdelivery device of FIG. 7B;

FIG. 8A illustrates a distal section of an example embodiment of a bonegraft delivery device including an endoscope;

FIG. 8B illustrates a distal section of another example embodiment of abone graft delivery device including an endoscope;

FIGS. 9A and 9B illustrate the bone graft delivery device of FIGS. 2Aand 2B with a guide bracket for a surgical navigation system; and

FIGS. 10A-10E illustrate a bone graft delivery device configured todeliver bone graft to an interbody device.

DETAILED DESCRIPTION

As shown in FIGS. 1A and 1B, an example embodiment of a bone graftdelivery device 100 generally includes a handle 102 having a trigger 110or other actuation mechanism, a tube 120 having a lumen therethrough,and a distal tip 130. In the illustrated embodiment, the bone graftdelivery device 100 is similar to a caulking gun. The handle 102 canhouse a supply of the desired bone graft material. The bone graftmaterial can be pre-loaded in the handle 102 or tube 120 or can besupplied to the handle, for example, via a cartridge that can beremovably coupled to the handle 102. In some embodiments, the device 100can further include a plunger 112 that is retracted proximally to allowthe handle to receive a cartridge or pre-loaded volume of bone graftmaterial. In some embodiments, for example as shown in the exampleembodiment of FIGS. 2A and 2B, the bone graft delivery device 100 doesnot include a distal tip 130. In some embodiments, the bone graftdelivery device does not include a rasping distal tip as described ingreater detail herein.

In use, the trigger 110 is actuated to deliver bone graft materialthrough the tube 120 and distal tip 130 to a desired surgical location.In some embodiments, the plunger 112 is simultaneously pushed distallyto help deliver bone graft material through the tube 120. In someembodiments, the trigger 110 or other actuation mechanism is configuredto deliver a controlled release amount of bone graft material duringactuation of the device, for example, ½ cc of bone graft material percomplete squeeze of the trigger 110. The trigger 110 or other actuationmechanism may be operated manually or by mechanical, battery powered,electric, pneumatic, or any other means of force.

In some embodiments, a portion of the handle 102 can include an openingconfigured to receive the bone graft material. For example, a base ofthe handle 102 can include a funnel 104 as shown in FIGS. 2A-2B and 3.In other embodiments, a side or another portion of the handle 102 caninclude a funnel 104 or other opening configured to receive the bonegraft material, for example as shown in FIGS. 2C-2K. Whereas someexisting bone graft delivery devices are only compatible with certain,e.g., pre-packaged, bone graft materials, the funnel 104 can be designedto advantageously allow the user to use any bone graft material orcombination of bone graft materials he or she wishes or deemsappropriate. For example, the user can use synthetic, autologous, stemcell, DMB, cadaveric, and/or any other available bone graft material.The handle 102 can further include a channel or funnel shaft 106extending therethrough connecting and in fluid communication with thefunnel 104 and tube 120. In use, the user can mix the desired bone graftmaterial in the funnel 104, then use the plunger 112 or other means toadvance the bone graft material through the channel 106 and into thetube 120 for delivery.

In some embodiments, the handle 102 includes a ratcheting mechanism 108configured to advance the plunger 112 and bone graft material from thefunnel 104 and through the channel 106 and tube 120 for delivery, asshown in FIGS. 4A-4E. The ratcheting mechanism 108 and plunger 112 canadvantageously create pressure on the bone graft material in the tube120 to improve delivery to the target location. In some embodiments, theplunger 112 fully or substantially seals with the inner diameter of thetube 120. This can create a vacuum within the tube 120 and/or canprovide greater pressure on the bone graft material to force the bonegraft material through the tube 120 and out of the distal end of thetube 120 or distal tip 130. In some embodiments, the plunger 112 or aportion of the plunger 112 is made of, for example, rubber silicone,which can help improve the seal with the tube 120 and/or can helpprovide pressure on the bone graft material. In some embodiments, theplunger 112 can be made of a plastic or another material and can includean elastomeric rubber stopper 115 at the distal end, for example asshown in FIG. 4O. The stopper 115 can be dual injection molded orco-molded with the plunger 112 so that the stopper 115 cannot normallybe removed from the plunger 112. As shown in FIG. 4X, the stopper 115can be molded onto or over a barb-shaped distal end of the plunger 112.The plunger 112 and ratcheting mechanism 108 can therefore allow thebone graft delivery device to extrude even highly viscous and/orgranular bone graft material.

In the illustrated embodiment, the ratcheting mechanism 108 includes acover 105 and a pawl 109 coupled to the trigger 110 via an arm 208. Thefunnel shaft 106 includes a window 107 in a portion of the shaft 106facing the pawl 109. The plunger 112 can be made of a rigid or flexiblematerial. For example, the plunger 112 can be plastic, carbon fiber,metal, or any other suitable material. The plunger 112 includes a seriesof teeth 114 and notches 113 located between the teeth 114 andconfigured to receive the pawl 109. The notches 113 can be generallytriangular. As shown, distal edges of the teeth 114 slope proximallytoward the outer edge of the plunger 112 to allow the pawl 109 to slidealong the distal edges in use. In some embodiments, extending thetrigger 110 away from the handle 102, for example to a positionperpendicular to the handle 102, causes the cover 105 to rest in andclose the window 107 of the funnel shaft 106, as illustrated in FIGS. 4Aand 4B, to allow for loading of the bone graft material through thefunnel 104 into the channel 106. In this position, the pawl 109 restsproximal to the window 107. The plunger 112 can be inserted into thefunnel 104 and channel 106 to advance some or all of the bone graftmaterial past the window 107. Once the bone graft material has beenloaded, the trigger 110 can be moved toward the handle 102 to anintermediate position, as shown in FIG. 4C. This moves the pawl 109distally so that the pawl 109 engages one of the notches 113 on theplunger 112 through the window 107. Movement of the trigger 110 to afinal position closest the handle 102 causes the pawl 109 to movedistally within the window 107 (or away from the funnel 104 and towardthe tube 120), thereby advancing the plunger 112 distally within thechannel 106 to force the bone graft material distally within the channel106 and/or tube 120, as shown in FIGS. 4D and 4E. The trigger 110 can bemoved back to the intermediate position to cause the pawl 109 to slideproximally along the plunger 112 and over one of the teeth 114 to engagea more proximal notch 113. The trigger 110 can be moved between theintermediate position and final position multiple times until the pawl109 has reached the proximal end of the plunger 112. The user canre-load the device 100 as needed during a procedure. The ratchetingmechanism 108 and trigger 110 in combination can advantageously providea mechanical advantage and allow the user to apply a greater force inoperating the bone graft delivery device 100 and/or delivering the bonegraft material compared to, for example, a standard syringe used todeliver bone graft material.

Another example embodiment of a handle 102 and ratcheting mechanism 108is shown in FIGS. 4F-4M. In this embodiment, the handle 102 includes atwo-part clamshell housing 102 a, 102 b that houses the funnel 104,funnel shaft 106, and ratcheting mechanism 108 assembly as shown in theexploded views of FIGS. 4F and 4G. The ratcheting mechanism 108 includesthe pawl 109 and a sheath 205 coupled to the trigger 110 via arm 208.The plunger 112 includes a series of sloped teeth 114 alternating withnotches 113 that are configured to receive the pawl 109. When thetrigger 110 is in the first position, as shown in FIGS. 4H and 41, thesheath 205 covers the pawl window 107 and the pawl 109 rests proximal tothe window 107. Movement of the trigger 110 to the intermediate positioncauses the sheath 205 and pawl 109 to move distally, exposing the window107 and allowing the pawl 109 to engage the plunger 112, as shown inFIGS. 4J and 4K. Movement of the trigger 110 to the final positioncauses the pawl 109 to move distally, advancing the plunger 112distally, as shown in FIGS. 4L and 4M.

Yet another example embodiment of a handle 102 and ratcheting mechanism108 is shown in FIGS. 4N-4T. In this embodiment, the funnel shaft 106includes an upper shaft portion 106 a and a lower shaft portion 106 b,and the lower shaft portion 106 b has an outer diameter smaller than anouter diameter of the upper shaft portion 106 a. As shown in FIGS.4P-4T, the outer diameter of the lower shaft portion 106 b can beapproximately the same as an inner diameter of the upper shaft portion106 a, and the shaft 106 can include a step 206 (shown in FIG. 4R) at atransition point between the upper shaft portion 106 a and lower shaftportion 106 b. In the illustrated embodiment, the upper 106 a and lower106 b shaft portions are integrally formed. In other embodiments, theupper 106 a and lower 106 b shaft portions can be separate pieces, and aproximal end of the lower shaft portion 106 b can be coupled to an innerperimeter of a distal end of the upper shaft portion 106 a. The uppershaft portion 106 a includes a first window 107 a for the pawl 109 and asecond window 107 b on an opposite side of the upper shaft portion 106 afrom the first window 107 a. A sheath 305 is disposed within or insidethe upper shaft portion 106 a, and in the illustrated embodiment, alever 308 extends from the trigger 110 and engages the sheath 305through the second window 107 b, as shown in FIGS. 4P-4T.

In some embodiments, the lever 308 is integrally formed with the sheath305. Alternatively, the lever 308 can be coupled to the sheath 305, forexample, with a pin 313. In some embodiments, the lever 308 includes abody 310 having a generally circular or ovular aperture 307, and an arm309 extending from one end of the body 310. The aperture 307 receivesthe funnel shaft 106 so that the body 310 surrounds the upper shaftportion 106 a. The sheath 305 includes a protrusion 311 that can extendthrough or over the second window 107 b when the sheath 305 is disposedin the upper shaft portion 106 a. The protrusion 311 is aligned with thelever body 310 with the protrusion 311 disposed in the aperture 307. Thepin 313 extends through holes in the body 310 and protrusion 311 tocouple the sheath 305 to the lever 308. In some embodiments, the pin 313is secured to the protrusion 311 and lever body 310 with a weld, glue,or other appropriate means. The free end of the arm 309 of the lever 308releasably engages the trigger 110. For example, the trigger 110 caninclude a track 116 configured to releasably receive the arm 309 asshown in FIGS. 4P and 4Q, and the arm 309 can engage the track 116 via,for example, a snap fit. In some embodiments, the trigger 110 is biasedor naturally rests at a distance from the handle body that holds the arm309 in the track 116. The trigger 110 can be flexed or allowed to moveslightly away from the handle body to release the arm 309.

In some embodiments, the sheath 305 has an outer diameter about the sameand slightly less than the inner diameter of the upper shaft portion 106a and a thickness about the same as a thickness of the lower shaftportion 106 b. The sheath 305 can include an upper lip 306, and a lengthof the sheath 305 can be selected such that in an initial loadingposition, shown in FIG. 4P, the lip 306 rests against an inner surfaceof the funnel 104 and a distal end of the sheath 305 rests against thestep 206. In the loading position, the sheath 305 covers the firstwindow 107 a. The dimensions of the upper shaft portion 106 a, lowershaft portion 106 b, and sheath 305 advantageously allow the sheath 305to be substantially flush with an inner surface of the upper shaftportion 106 a and step 206 and provide a substantially smooth andconstant-diameter inner passageway from the sheath 305 to the lowershaft portion 106 b. The bone graft delivery device of FIGS. 4N-4T alsoincludes a pusher rod 312 and a tube end cap 124.

To load bone graft material, the lever 308 is coupled to the trigger 110so that the sheath 305 sits in the initial loading position shown inFIG. 4P. Bone graft material 10 is loaded into the funnel 104, and thepusher rod 312 can be inserted into the funnel 104 to help urge the bonegraft material 10 through the sheath 305 and lower shaft portion 106 band into the tube 120 as shown in FIG. 4Q. In some embodiments, thepusher rod 312 is made of, for example, a glass filled or rigid polymermaterial. The tube end cap 124 inhibits or prevents the bone graftmaterial 10 from exiting the distal end of the tube 120 during theloading process and until the user wishes to deliver the bone graftmaterial 10. The tube end cap 124 can be attached to the distal end ofthe tube 120 via a threaded coupling, friction fit, or other suitablemeans. In the illustrated embodiment, the tube 120 includes externalthreads 125 b at or near the distal end configured to mate with internalthreads in the tube end cap 124. Once the bone graft material 10 isloaded, the pusher rod 312 is removed, and the lever 308 is releasedfrom the trigger 110 as shown in FIG. 4R. As shown, release of the lever308 causes or allows the lever to move toward the funnel, thereby alsomoving the sheath 305 proximally to expose the first window 107 a andallow the pawl 109 to enter the shaft 106 through the first window 107a. The plunger 112 can be inserted before or after releasing the lever308 and extends through the sheath 305, upper shaft portion 106 a, andlower shaft portion 106 b and into the tube 120 as shown in FIG. 4S.When the plunger 112 is inserted and the lever 308 is released so thatthe first window 107 a is exposed, the pawl 109 engages one of thenotches 113 on the plunger 112. The lever 308 can advantageously providethe user with a greater mechanical advantage and/or greater control inmoving the sheath 305 proximally to expose the first window 107 a. Inother embodiments, the sheath includes a protrusion 316 without a leveras shown in FIGS. 4U and 4V. The user can use the protrusion 316 to liftor lower the sheath 305.

The tube end cap 124 is removed when the user wishes to deliver the bonegraft material 10 through the tube 120. Movement of the trigger 110toward the handle causes the pawl 109 to move distally, advancing theplunger 112 distally, as shown in FIG. 4T. The trigger 110 is moved awayfrom and toward the handle to advance the plunger 112 and bone graftmaterial 10 through the tube 120 in discreet increments. Of course,other ratcheting mechanisms and/or other mechanisms for advancing bonegraft material through the handle 102 and/or tube 120 are also possible.

In some embodiments, the funnel 104 or other opening for loading of bonegraft material can be positioned in the handle 102 in locations otherthan a proximal end or base of the handle 102. For example, in theexample embodiment of FIGS. 2C-2E, the handle 102 is configured suchthat the trigger 110 and a grip 111 extend from a main body portion 103of the handle 102. As shown, the funnel 104 is located on an oppositeside of the body portion 103 from the grip 111 and trigger 110. A mainchannel 406 extends through the handle 102 from an opening in a proximalend of the body portion 103 to an opening in a distal end of the bodyportion 103 and is in fluid communication with the tube 120. The funnelshaft 106 extends from the funnel 104 to intersect the main channel 406as shown in FIGS. 2D and 2E. In the illustrated embodiment, the funnel104 and funnel shaft 106 are oriented at an angle 1 relative to the mainchannel 406. The angle can advantageously help direct bone graftmaterial inserted into the funnel 104 and funnel shaft 106 distallytoward the tube 120. The bone graft delivery device can include a pusherrod 312 as shown in FIG. 2E to help urge bone graft material from thefunnel 104 through the funnel shaft 106 and into the main channel 406.In some embodiments, the pusher rod 312 can be configured such that whenfully inserted into the funnel 104 and funnel shaft 106, a distal end314 of the pusher rod 312 rests at the intersection of the funnel shaft106 with the main channel 406 to at least partially or substantiallyclose the main channel 406. The distal end 314 of the pusher rod 312 canbe formed at an angle with the angle corresponding to the angle of thefunnel shaft 106 so that the distal end 314 is continuous with a wall ofthe main channel 406 when inserted into the funnel shaft 106. In suchembodiments, the pusher rod 312 can be configured to remain in placeduring delivery of bone graft material.

The handle 102 of FIGS. 2C-2E can include any of the ratchetingmechanisms described herein or any other suitable ratcheting mechanism.In use, once the bone graft material is loaded via the funnel 104, theplunger 112 is inserted from the proximal opening of the main channel406 through the handle 102 and into the tube 120. The main channel 406can include a window to allow the pawl to engage notches on the plunger.In use, movement of the trigger 110 toward the grip 111 can cause thepawl to advance the plunger and bone graft material distally in the tube120. Releasing the trigger 110 to allow the trigger 110 to move awayfrom the grip 111 causes the pawl to slide proximally along the plungerto engage a more proximal notch. If the window is located proximal tothe intersection of the funnel shaft 106 with the main channel 406, thecover, sheath, or the like can be omitted from the ratcheting mechanism.In such embodiments, the bone graft material does not pass through theportion of the main channel 406 having the window, so the window can beleft uncovered during loading. In some embodiments, the handle 102 ofFIGS. 2C-2E does not include a ratcheting mechanism, and a plunger canbe inserted into and advanced through the main channel 406 and tube 120to advance and deliver the bone graft material.

FIGS. 2F-2H illustrate an alternative embodiment in which the funnel 104is located on the same side or surface of the handle 102 as the trigger110. In the illustrated embodiment, the funnel 104 is advantageouslylocated distal to the trigger 110 so that the pusher rod 312, wheninserted into the funnel 104, does not interfere with operation of thetrigger 110. The embodiment of FIGS. 2F-2H can also include a mainchannel 406, an angled funnel 104, funnel shaft 106, and distal end 314of the pusher rod 312, and any suitable ratcheting mechanism similar tothe embodiment shown in FIGS. 2C-2E and discussed above. In use, aplunger is inserted into the main channel 406 and tube 120. In theillustrated embodiment, the main channel 406 includes a window 107 toallow the pawl 109 to engage notches on the plunger when the plunger isinserted. Movement of the trigger 110 towards the handle 102 causes thepawl 109 to move distally within the window 107, thereby advancing theplunger and bone graft material. Movement of the trigger 110 away fromthe handle causes the pawl 109 to slide proximally along the plunger andengage a more proximal notch. In the illustrated embodiment, the window107 and ratcheting mechanism are located proximal to the intersection ofthe funnel shaft 106 with the main channel 406, and the ratchetingmechanism does not include a cover or sheath. FIGS. 2I-2K illustrateanother alternative embodiment, similar to the embodiment of FIGS.2F-2H, with the funnel 104 positioned on a side or surface of the handle102 lateral or generally perpendicular to the trigger 110. In otherembodiments, the funnel 104 can be located on any side or surface of thehandle 102, for example, opposite the trigger 110, to either side of thetrigger, or any other position around the handle 102. The funnel 104 canalso be located distal to, even with, or proximal to the trigger 110.

As shown in FIGS. 1A and 1B, the tube 120 of any of the devicesdescribed herein can include a permanent bend or curve that may beuseful in positioning the device 100 at a desired location, for example,a space between two spinal discs, transverse process, facet joint,lamina, or other target area. Alternatively, the tube 120 may bestraight, for example, as shown in FIGS. 2A and 2B, to deliver bonegraft material directly into a desired location such as a disc space,transverse process, facet joint, lamina, or other target area. In someembodiments, the tube 120 is somewhat flexible or repositionable and canbe manipulated to bend or curve the tube 120 as needed to reach thedesired location. In some embodiments, the tube 120 is made of a rigidmaterial, for example, a plastic, composite, or metal. In someembodiments, the tube 120 can be at least partially transparent, whichcan allow the user to view, for example, the volume or position of thegraft material within the tube 120. The tube 120 can also include volumemarkings to allow the user to monitor the amount of graft materialdelivered to the target site and remaining in the tube 120, for example,as shown in FIGS. 4N-4O. In some embodiments, the tube 120 includes oneor more radiopaque markers to allow for visualization on, for example,x-ray or fluoroscopy. The tube 120 is generally hollow to allow for thepassage of bone graft material through the lumen of the tube 120. Thetube 120 and lumen can have various diameters, for example, fordifferent applications and/or target locations.

In some embodiments, the tube 120 can be integrally formed with orpermanently coupled to the handle 102. In other embodiments, the bonegraft delivery device 100 can have a modular construction so thatvarious tubes 120 can be selected and coupled to the handle 102. Such amodular construction can advantageously allow the user to interchangestraight and curved handles and/or handles having various other featuresdepending on the target location, particular patient, and/or otherfactors. As shown in FIGS. 5A and 5B, the distal end of the handle 102or any of the handles described herein can include a recess 60configured to receive a base 62 coupled to or integrally formed with thetube 120. The base 62 can be coupled to the tube 120 via a threadedcoupling, press fit, or any other suitable means. For example, in theembodiment shown in FIGS. 4N-4T, the tube 120 includes external threads125 a at or near a proximal end of the tube configured to mate withinternal threads in the base 62. As shown in FIG. 5B, the base 62 caninclude an aperture to allow fluid communication between the funnelshaft 106 in the handle 102 and the tube 120. The tube 120 can also becoupled to the handle 102 by any other appropriate means.

As shown in FIGS. 6A-6C, a distal end of the tube 120 (which may be anyof the tubes described herein) can include a tip 130. The tip 130 can beintegrally formed with or coupled, removably or permanently, to the tube120. In some embodiments, the tube 120 and tip 130 can be a modularsystem such that different tips can be selected and coupled to the tube120 for different procedures and/or target locations. The tip 130 can bemade of a metallic, radiopaque material to facilitate visualization on,for example, fluoroscopy or x-ray. Alternatively, the tip 130 may bemade of another material, for example a durable medical plastic or acomposite material, and may include markers to facilitate visualization.In the illustrated embodiment, the tip 130 is somewhat bullet-shapedwith a generally triangular cross-section; however, other shapes andconfigurations are also possible. For example, the tip 130 can begenerally flat as shown in the example embodiments of FIGS. 6D-6G. Insome embodiments, for example as illustrated in the example embodimentof FIG. 6H-6I, the tip 130 is generally conical. This shape can bebeneficial for delivering bone graft material to, for example, a facetjoint. In some embodiments, the tip 130 is pointed and/or sharp todissect or split muscle and tissue as it is advanced through thepatient's skin and body to the surgical location. Alternatively, the tip130 can be blunt to allow for displacement of muscle without risk ofcutting of nerves or other tissue. The tip may have a single or multipleopenings 132 in fluid communication with the tube 120 lumen andconfigured to deliver the bone graft material 10 from the tube 120, asshown in FIG. 6G, to the desired location.

In some embodiments, at least one side or area of the tip 130 includes aseries of jagged edges or other suitable surface 134 configured to serveas a rasp for scraping bone. As shown in FIGS. 6A and 6C, the edges maybe triangular in shape, and as shown in in FIGS. 6D-6G, they may beflat. With respect to the embodiment shown in FIGS. 6D-6G, the jaggededges may form a plurality of flat surfaces parallel with each other allwithin the same plane. In some embodiments, for example as shown inFIGS. 6H-6I, the rasping surface 134 can include a roughened surfaceextending around an outer surface of the tip. The rasp may be operatedmanually or by mechanical, battery powered, electric, pneumatic, or anyother means of force to allow for decortication of the area to receivethe bone graft material. In some embodiments, the opening(s) 132 fordelivering bone graft material is located on a side(s) or portion(s) ofthe tip 130 that does not include a rasping surface, for example asshown in FIGS. 1A-1B and 6A-6C. In some embodiments, the opening(s) 132is located on a side(s) or portion(s) that does include a raspingsurface, for example as shown in FIGS. 6D-6I and 8A.

In some embodiments, the delivery device 100 includes a sleeve slidablyor telescopingly disposed over the tip 130. In some embodiments, thesleeve can extend to a proximal end of the tube 120 adjacent the handle102 so that a user can distally advance or proximally retract the sleeveby manipulating a proximal end of the sleeve. In other embodiments, thesleeve extends over only a portion of the tube 120 or over only the tip130 and the delivery device 100 includes an actuating mechanism thatallows the sleeve to be advanced and retracted. The sleeve can bedisposed over the tip 130 during insertion of the tip 130 to the targetarea to advantageously protect skin, tissue, and/or muscle along theinsertion path from damage or injury from the rasping surface 134 and toallow the tip 130 to pass through the skin, tissue, and/or muscle moreeasily. Once the tip is positioned in the target location, the sleevecan be proximally retracted to expose the rasping surface 134 fordecortication of the target area. After decortication and/or afterdelivery of the bone graft material, the sleeve can be distally advancedto cover the rasping surface 134 for withdrawal of the tip 130 from thebody.

In some embodiments, the distal end of the tube 120 does not include arasping tip 130, for example as shown in FIGS. 7A-7C. In some suchembodiments, an elongate shaft 150 having a burr 152 at a distal end canbe inserted through the tube 120 as needed or desired to decorticate atarget area, for example as shown in FIGS. 7B and 7C. The burr 152 canhave various shapes and configurations, for example, a generallyspherical shape as shown in FIGS. 7B and 7C, a bullet shape similar tothe distal tip 130 shown in FIGS. 6A-6C, a generally flat shape similarto the distal tip 130 shown in FIGS. 6D-6G, a generally conical shape asshown in FIGS. 6H-6I, or any other suitable shape or configuration. Theuse of a separate instrument for decortication can advantageously allowthe user to select different burrs, rasps, or the like for differentpatients, target areas, or situations. The elongate shaft 150 and burr152 can be operated manually. Alternatively, a proximal end of the shaft150 can be coupled to a drill 154 or another device to providedecortication by mechanical, battery powered, electric, pneumatic, orany other means of force.

In some such embodiments, the distal end of the tube 120 includes aradiopaque ring or other marker 122 as shown in FIG. 7C to allow forvisualization on, for example, x-ray or fluoroscopy. In someembodiments, the radiopaque ring 122 can be used to assist the user inassessing depth during the procedure. In some embodiments, for exampleas shown in FIG. 4O, the radiopaque ring 122 can be press fit or snappedonto the distal end of the tube 120 during manufacturing and assembly.In some embodiments, for example as shown in FIG. 4W, the radiopaquering 122 can be press fit or snapped into a groove 222 near a distal endof the tube 120. In the illustrated embodiment, the groove 222 is distalto the threads 125 b configured to receive the tube end cap 124 and istherefore covered by the tube end cap 124 when the tube end cap 124 iscoupled to the tube 120. In some embodiments, the radiopaque ring 122can be co-molded with the tube 120 during manufacturing.

In some embodiments, the bone graft delivery device 100 can beconfigured to deliver bone graft material inside an interbody cage orother interbody device that has been disposed within a disc space. Insome cases, inserting an interbody cage after delivering bone graftmaterial can disrupt the placement of the bone graft material.Delivering the bone graft material after inserting the interbody cageand inserting the bone graft material within the interbody cage can helpensure the bone graft material is placed where desired or required. Insome embodiments, an attachment member can be provided to couple thedistal end of the tube 120 of the bone graft delivery device 100 to theinterbody cage. Bone graft material is delivered through the tube 120and attachment member and into the interbody cage. Various attachmentmembers can be manufactured and/or provided for use with variousinterbody cages or other interbody devices. In some embodiments, thedistal end of the tube 120 itself includes features configured to engagecorresponding features on an interbody device. FIGS. 10A-10E illustratean example embodiment of a tube 120 having a distal end 122 configuredto engage an interbody cage 400. The distal end 122 of the tube 120 canbe coupled to the cage 400 after the cage 400 has been placed in thedisc space as shown in FIGS. 10A and 10B. As shown in FIG. 10D, thedistal end 122 of the tube 120 includes alternating ridges 121 andrecesses 123 configured to mate with corresponding recesses 404 andridges 402 on the cage 400. In some such embodiments, various tubes 120with different engagement features can be manufactured and/or providedfor use with various interbody devices, and the user can select theappropriate tube 120 after selecting the interbody device to be used.

In some embodiments, the bone graft delivery device 100 can include anendoscope or endoscopic camera to allow for visualization duringinsertion of the tip 130 to the target area, decortication, and/ordelivery of the graft material. This can advantageously allow thephysician to visualize muscles, nerves, and other tissue and structuresunder the skin to help avoid and inhibit damage to sensitive structures.As shown in FIG. 8A, an endoscope 140 can extend along the tube 120 andcan be removably or permanently coupled to the tube 120. In someembodiments, the endoscope 140 or camera can extend through the lumen ofthe tube 120, for example as shown in FIG. 8B.

The bone graft delivery device 100 can also or alternatively be used inconjunction with various image-guided surgery systems and devices, suchas, for example, StealthStation° Navigation Systems available fromMedtronic or other navigation systems. In some embodiments, for exampleas shown in the example embodiment of FIGS. 9A and 9B, the bone graftdelivery device includes a guide 170 having markers 172 configured to bevisualized with, for example, fluoroscopy or x-ray. The guide 170 caninclude a sheath 174 configured to receive the tube 120 to couple theguide 170 to the bone graft delivery device. A surgical navigationsystem can include an imaging modality, such as an X-ray or CT scanneror fluoroscope, and a camera. In use, during preparation for animage-guided surgical procedure, a reference frame, which can includeradiopaque markers, is attached to a pin positioned in a referencelocation in the patient's spine or other target area. Images are taken,and the image data is transferred to the navigation system forprocessing and registration. During the procedure, the camera can trackthe position of the markers 172 on the guide 170 relative to the markerson the reference frame. The navigation system can process imagesobtained by the camera and/or an imaging modality to display theposition of the bone graft delivery device on the pre-operative images.In some embodiments, the navigation system can process images obtainedby an endoscopic camera extending alongside or through the tube 120 asdescribed herein.

In some embodiments, one or more handles 102 of a bone graft deliverydevice can be provided in a system or kit with one or more tips 130,tubes 120, and/or other instruments. The kit can allow a surgeon orother medical personnel to select an appropriate tube 120 and/or tip 130for the particular patient, procedure, and/or treatment location. Asdescribed above, certain tip 130 configurations can be suited forcertain target locations. For some procedures, the surgeon may select acurved or straight tube 120 to help improve access to the particulartarget location. In some embodiments, the kit can include an endoscopiccamera. In some embodiments, the kit can include one or more separaterasping instruments. The kit can include various other instruments thatmight be used during a orthopedic procedure.

In one embodiment, the device 100 described herein may be used inminimally invasive spinal surgery. For example, in a conventionalposterolateral spine procedure, screws and or fusion cages may bedelivered to adjacent vertebrae using small incisions made in apatient's back. It may additionally be desirable to deliver bone graftmaterial to the surgical location, e.g., to the transverse processes,disc spaces, lamina, or facet joints, through one of these smallincisions. The device described herein is sized to be delivered througha minimally invasive opening made in the patient's skin (e.g., through askin incision of 4 cm or less), and configured so that the tip can bepositioned adjacent a pedicle screw or other desired location. Theoptional curvature of the tube 120 can facilitate positioning of the tip130 at desired spinal locations and allows, for example, insertion ofthe device 100 through an incision over one vertebra, and positioning ofthe tip 130 at an adjacent vertebra. Alternatively, the device can bedelivered through any desired opening made in the patient's skin (e.g.,minimally invasive, mini-open, or open). If needed, the optional jaggededges or other surface 134 on the device can be used to decorticatedesired bone locations, causing bleeding of the bone and creating asurface that promotes bone fusion. The trigger 110 or other actuationmechanism can then be actuated to deliver bone graft material throughthe tube 120 lumen and optional openings 132 in the tip 130 to promotefusion of the bone.

In some embodiments, an endoscope or camera can be inserted through thetube 120 and used to help guide the physician or other medicalprofessional to the target location and/or to allow the physician toevaluate the area. If the physician wants to decorticate the bone, thephysician can remove the endoscope or camera, insert the shaft 150having the burr 152 or another suitable rasping instrument, anddecorticate the target area. In some embodiments, the tube 120 can beinserted into the patient with the shaft 150 or other rasping instrumentalready inserted or with a rasping tip 130 attached and the physiciancan use an endoscope, camera, navigation system, or the like placedalongside, adjacent, or proximal the tube 120 to navigate to and/orevaluate the target area. Once the target location is ready, thephysician can remove the shaft 150 or other rasping instrument ifpresent and deliver the bone graft material, for example, using thetrigger 110.

Although use of the device 100 has been described with respect to anexample spinal procedure, the device 100 can also be used in otherspinal procedures and other orthopedic applications to deliver bonegraft material to other locations in the body (for example, the femur ortibia).

Various modifications to the implementations described in thisdisclosure may be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the principles and features disclosed herein. Variouscombinations and subcombinations of the various features describedherein are possible. For example, a bone graft delivery device caninclude a handle and tube and may or may not include a distal raspingtip. The tube can be integrally formed with the handle and/or a distalrasping tip and/or any or all of the components can have a modularconfiguration such that various tubes and/or distal tips can be selectedand exchanged as desired by the surgeon or other user. A bone graftdelivery device can have a curved or straight tube. A distal tip canhave any suitable configuration, including bullet-shaped, flat, conical,or any other configuration. A bone graft delivery device can beconfigured to received and/or supplied with various endoscopes, othercameras or imaging equipment, and/or guide brackets for imagingequipment. A bone graft delivery device can include any suitableratcheting mechanism to advance bone graft material through the devicefor delivery and may include a plunger and/or pusher rod. Certainembodiments of the invention are encompassed in the claim set listedbelow.

What is claimed is:
 1. A bone graft delivery system, comprising: a bonegraft delivery device comprising: an elongate tube; a lumen extendingthrough the elongate tube, the lumen having a uniform cross-sectionalong an entire length of the lumen from a proximal end of the lumen toa distal end of the lumen; and a plunger configured to be received inthe lumen, the plunger comprising a plurality of notches; and aninterbody device configured to be removably coupled to the bone graftdelivery device; wherein the plunger is configured to advance throughthe lumen of the elongate tube to advance bone graft material throughthe lumen.
 2. The system of claim 1, wherein the interbody devicecomprises an interbody cage.
 3. The system of claim 1, wherein the bonegraft delivery device comprises an attachment member, wherein theinterbody device is configured to be removably coupled to the attachmentmember.
 4. The system of claim 1, wherein the distal end of the elongatetube is configured to be removably coupled to the interbody device. 5.The system of claim 4, wherein the distal end of the elongate tubecomprises alternating ridges and recesses and the interbody devicecomprises corresponding recesses and ridges, wherein the ridges andrecesses of the elongate tube are configured to mate with correspondingrecesses and ridges of the interbody device.
 6. The system of claim 1,further comprising a handle at the proximal end of the tube, the handlecomprising a trigger configured to be actuated to deliver bone graftmaterial through the tube.
 7. The system of claim 1, wherein theinterbody device comprises a plurality of openings.
 8. The system ofclaim 1, wherein the interbody devices comprises a plurality ofprotrusions configured to engage adjacent intervertebral discs.
 9. Thesystem of claim 1, wherein the elongate tube is pre-loaded with asynthetic bone graft material.
 10. The system of claim 1, furthercomprising a sleeve configured to slide over at least a portion of theelongate tube.
 11. A method for delivering bone graft material to asurgical location, comprising: placing an interbody device within a discspace of a patient; mating a distal end of an elongate tube of a bonegraft delivery device to the interbody device while the interbody deviceis positioned in the disc space or coupling the elongate tube to theinterbody device by way of an attachment member while the interbodydevice is positioned in the disc space, wherein bone graft material isloaded in the bone graft delivery device; and advancing the bone graftmaterial through a lumen of the elongate tube of the bone graft deliverydevice using a plunger comprising a plurality of notches.
 12. The methodof claim 11, wherein the interbody device comprises an interbody cage.13. The method of claim 11, further comprising delivering the bone graftmaterial within the interbody device.
 14. The method of claim 11,further comprising selecting the elongate tube from a plurality ofelongate tubes for use in the bone graft delivery device, whereincoupling the elongate tube to the interbody device comprises couplingthe selected elongate tube to the interbody device.
 15. The method ofClaim of claim 11, wherein the distal end of the elongate tube comprisesalternating ridges and recesses configured to mate with correspondingrecesses and ridges of the interbody device, wherein mating the distalend of the elongate tube to the interbody device comprises mating theridges and recesses of the distal end of the elongate tube to thecorresponding recesses and ridges of the interbody device.
 16. Themethod of claim 11, further comprising actuating a trigger to cause thedistal advancement of the plunger within the lumen of the elongate tube.17. A bone graft delivery system, comprising: a bone graft deliverydevice comprising: an elongate tube; a lumen extending through theelongate tube, the lumen having a uniform cross-section along an entirelength of the lumen from a proximal end of the lumen to a distal end ofthe lumen; a plunger configured to be received in the lumen; and atrigger configured to be actuated to deliver bone graft material throughthe tube; and an interbody device configured to be removably coupled tothe bone graft delivery device.
 18. The system of claim 17, wherein theinterbody device comprises an interbody cage.
 19. The system of claim17, wherein the bone graft delivery device comprises an attachmentmember, wherein the interbody device is configured to be removablycoupled to the attachment member.
 20. The system of claim 17, whereinthe distal end of the elongate tube is configured to be removablycoupled to the interbody device.
 21. The system of claim 20, wherein thedistal end of the elongate tube comprises alternating ridges andrecesses and the interbody device comprises corresponding recesses andridges, wherein the ridges and recesses of the elongate tube areconfigured to mate with corresponding recesses and ridges of theinterbody device.
 22. The system of claim 17, wherein the interbodydevice comprises a plurality of openings.
 23. The system of claim 17,wherein the interbody devices comprises a plurality of protrusionsconfigured to engage adjacent intervertebral discs.
 24. The system ofclaim 17, wherein the elongate tube is pre-loaded with a synthetic bonegraft material.
 25. The system of claim 17, further comprising a sleeveconfigured to slide over at least a portion of the elongate tube.
 26. Amethod for delivering bone graft material to a surgical location,comprising: placing an interbody device within a disc space of apatient; mating a distal end of an elongate tube of a bone graftdelivery device to the interbody device while the interbody device ispositioned in the disc space or coupling the elongate tube to theinterbody device by way of an attachment member while the interbodydevice is positioned in the disc space, wherein bone graft material isloaded in the bone graft delivery device; and advancing the bone graftmaterial through a lumen of the elongate tube of the bone graft deliverydevice using a plunger, wherein the plunger is advanced through thelumen of the elongate tube by a trigger.
 27. The method of claim 26,wherein the interbody device comprises an interbody cage.
 28. The methodof claim 26, further comprising delivering the bone graft materialwithin the interbody device.
 29. The method of claim 26, furthercomprising selecting the elongate tube from a plurality of elongatetubes for use in the bone graft delivery device, wherein coupling theelongate tube to the interbody device comprises coupling the selectedelongate tube to the interbody device.
 30. The method of claim 26,wherein the distal end of the elongate tube comprises alternating ridgesand recesses configured to mate with corresponding recesses and ridgesof the interbody device, wherein mating the distal end of the elongatetube to the interbody device comprises mating the ridges and recesses ofthe distal end of the elongate tube to the corresponding recesses andridges of the interbody device.